MS in Advanced Biotherapeutics: Manufacturing & Regulatory Affairs

College

Kanbar College of Design, Engineering & Commerce

Degree

Master of Science

Campus

East Falls

Format

Hybrid (Online and On Campus)

Curriculum

The Advanced Biotherapeutics: Manufacturing & Regulatory Affairs (ABMRA) degree unites the strengths of two prestigious regional academic institutions. The curriculum combines theoretical and hands-on manufacturing-process and analytical experience with mandated regulatory and quality assurance expectations that are essential to establishing and verifying good manufacturing, laboratory, clinical and pharmacovigilance practices.

Students must complete a minimum of 15 credits in Biopharmaceutical Manufacturing from Thomas Jefferson University, including the following required courses:

  • ENGR 609 – Bioprocess Engineering for Scientists (3 credits)
  • ENGR 621 – Introduction to Biopharmaceutical and Biologics Production (3 credits)
  • ENGR 611 – Principles of Biopharmaceutical Process Engineering (3 credits)
  • ENGR 604 – Biopharmaceutical Process Operations (3 credits)

Students may then choose at least one (1) course from the following list of electives:

  • ENGR 601 – Introduction to Upstream Unit Operations: Cell Culture and Harvesting (3 credits)
  • ENGR 602 – Introduction to Downstream Unit Operations: Purification, Buffer Exchange and Concentration (3 credits)
  • ENGR 613 – Vector and Cell Line Design (3 credits)
  • ENGR 622 – Biotherapeutic Formulation (1.5 credits)
  • ENGR 614 – Vaccine Formulation (1.5 credits)
  • ENGR 618 – Technical and Regulatory Aspects of Analytical Method Validation (1.5 credits)
  • ENGR 612 – Emerging Therapeutics (1.5 credits)

Students must also complete five (5) Temple University Regulatory Affairs & Quality Assurance (RAQA) courses (totaling 15 credits), including the following required courses:

  • Drug Development (5459) (3 Credits)
  • Biologics / Biosimilars: A Regulatory Overview (5515) (3 Credits)
  • Global CMCs – Biologics (5577) (3 Credits)
  • Vaccines: RA and QA Aspects (5572) (3 Credits)

Students may then choose at least one (1) course from the following list of electives:

  • Biotechnology: Bioprocess Basics (5471) – (3 credits)
  • Pharmaceutical Biotechnology (8005) – (3 credits)
  • Statistical Quality Control (5451) – (3 credits)
  • Validation of FUE (Facilities, Utilities and Equipment) (5468) – (3 credits)
  • Process Validation (5474) – (3 credits)
  • Advanced Good Manufacturing Practices – Defining “c” (5479) – (3 credits)
  • Production of Sterile Products (5492) – (3 credits)
  • Sterilization Processes (5493) – (3 credits)
  • Development of Sterile Products (5501) – (3 credits)
  • Microbiological Concepts in Pharmaceutical Manufacturing (5512) – (3 credits)
  • Regulatory eSubmissions (5514) – (3 credits)
  • Cleaning Validation (5516) – (3 credits)
  • Clinical Drug Safety and Pharmacovigilance (5538*) – (3 credits)
  • Regulatory Intelligence (5544) – (3 credits)
  • Post-Marketing Safety Surveillance (5571*) – (3 credits)
  • Quality Systems Management (5574) – (3 credits)
  • Regulatory Sciences: Managing the Guidelines for Quality (5575) – (3 credits) 
  • Process Analytical Technology (PAT) (5625) – (3 credits)
  • Statistical Design of Experiments (DOE) (5627) – (3 credits)
  • Process Monitoring (5629) – (3 credits)

*Students may enroll in one of these courses, but not both.